4-acetylmorpholine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1967-03-22 to 1967-04-14

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study predating guidelines and GLP, but scientifically fully acceptable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

no guideline followed

Deviations:

not applicable

Principles of method if other than guideline:

other: BASF test (close to Draize test), occlusive, 3 rabbits, intact skin, 20 h exposure (among others)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-acetylmorpholine

EC Number:

216-913-4

EC Name:

4-acetylmorpholine

Cas Number:

1696-20-4

Molecular formula:

C6H11NO2

IUPAC Name:

1-(morpholin-4-yl)ethan-1-one

Details on test material:

- Name of test material: N-Acetylmorpholin

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.83 kg (male); 3.10 kg (female); 2.72 kg (male)

ENVIRONMENTAL CONDITIONS
- no data

IN-LIFE DATES: From: 1967-03-29 To: 1967-04-14

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

undiluted (2 mL / animal (corresponds to 2.23 g)

Duration of treatment / exposure:

1, 5 or 20 minutes
20 hours (data selected as worst case for 4 h test)

Observation period:

Animal 1 (male, 7.6.645): 8 days, (day 3 and 4 lacking)
Animal 2 (female, 6.6.571): 5 days, (day 3 and 4 lacking)
Animal 3 (male, 5.6.427): 3 days

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: at six sites per rabbit along the dorsum (plus left ear, not considered)
- % coverage: approximately 6 cm2 each


REMOVAL OF TEST SUBSTANCE
- Washing: yes, mild detergent (50% Lutrol)


SCORING SYSTEM: Draize score (converted from recorded grading with detailed instructions provided by data owner)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24 h, 48 h, and 5, 6, 7, 8 days (mean)

Score:

0

Max. score:

4

Remarks on result:

other: Exposure duration 20 h (instead of 4 h, OECD 404)

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24 h, 48 h and 5 days (mean)

Score:

0

Max. score:

4

Remarks on result:

other: Exposure duration 20 h (instead of 4 h, OECD 404)

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24 h, 48 h, 72 h (mean)

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Exposure duration 20 h (instead of 4 h, OECD 404)

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 h, 48 h, and 5, 6, 7, 8 days (mean)

Score:

0

Max. score:

4

Remarks on result:

other: Exposure duration 20 h (instead of 4 h, OECD 404)

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 h, 48 h, and 5, 6, 7, 8 days (mean)

Score:

0

Max. score:

4

Remarks on result:

other: Exposure duration 20 h (instead of 4 h, OECD 404)

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24 h, 48, 72 h (mean)

Score:

0

Max. score:

4

Remarks on result:

other: Exposure duration 20 h (instead of 4 h, OECD 404)

Irritant / corrosive response data:

not irritating (minimal signs of skin irritation (erythema grade 1) were noted after the 20 h exposure period in one animal at the 24h and 48h reading).

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU